Proyecto BEBE: The Effect of Babywearing Education on Breastfeeding Exclusivity

NCT04376021 | Completed

• 1 other identifier: 28
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

To test the hypothesis that increased mother-infant physical contact affects the likelihood of mothers exclusively breastfeeding their child for the first six months of life, the investigators will randomly assign half of the participating mothers to receive a baby carrier to use with their baby (to facilitate increased physical contact) while the other half of babies and mothers will receive standard care.

Conditions

Breastfeeding, Exclusive; Mother-Infant Interaction; Postpartum Depression

Outcome Measures

Primary Outcomes (1)

• Proportion of infant feeds coming from breastmilk versus formula

  Self-report feeding log

  Postpartum Week 24

Secondary Outcomes (3)

• Score on Edinburgh Postnatal Depression Scale (EPDS)

  Postpartum Week 6

• Score on the Mother-Infant Bonding Questionnaire

  Postpartum Week 24

• Score on the Proximal Care Beliefs Questionnaire

  Postpartum Week 12

Study Arms (2)

Physical Contact

EXPERIMENTAL

Baby carrier (and education) provided to mother to increase physical contact with baby

Behavioral: Babywearing

Control

NO INTERVENTION

No intervention

Interventions

Babywearing BEHAVIORAL

Increase mother-infant physical contact through babywearing

Physical Contact

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible to participate in this study, participants:
• Must be a current participant in the CBHS program
• Must be 18 years of age or older
• Must be currently pregnant
• Must be fluent in either Spanish or English
• Must have consistent access to a smartphone with internet access (to fill out surveys and feeding logs)
• Must have a functioning email address Must be willing to share certain personal information with the researchers

You may not qualify if:

• Having a birth that does not result in a live, healthy, singleton infant.

Sponsors & Collaborators

• Nurturely: lead
• Project Concern International: collaborator

Study Sites (1)

Project Concern International

San Diego, California, 92105, United States

Location

Related Publications (2)

• Little EE, Bain L, Hahn-Holbrook J. Randomized controlled trial to prevent postpartum depressive symptomatology: An infant carrier intervention. J Affect Disord. 2023 Nov 1;340:871-876. doi: 10.1016/j.jad.2023.08.044. Epub 2023 Aug 15.

  PMID: 37586649 DERIVED

• Little EE, Cioffi CC, Bain L, Legare CH, Hahn-Holbrook J. An Infant Carrier Intervention and Breastfeeding Duration: A Randomized Controlled Trial. Pediatrics. 2021 Jul;148(1):e2020049717. doi: 10.1542/peds.2020-049717. Epub 2021 Jun 30.

  PMID: 34193622 DERIVED

MeSH Terms

Conditions

Breast Feeding; Depression, Postpartum

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Emily E Little, PhD

  Nurturely

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Founder & Director

Study Record Dates

• First Submitted: March 4, 2018
• First Posted: May 6, 2020
• Study Start: February 6, 2018
• Primary Completion: June 26, 2019
• Study Completion: June 26, 2019
• Last Updated: May 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)